Rheumatoid ArthritisNCT01646385

Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry

An observational study of Rheumatoid Arthritis, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: etanercept and non-biologic anti-rheumatic drugs
How many people: 6,393 participants
Where: No sites listed yet
Study dates: Feb 2012to Aug 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: adult patients with a diagnosis of rheumatoid arthritis

Who may be able to join

adult
rheumatoid arthritis
group 1: initiating etanercept as first biologic therapy
group 2: DAS28<4.2, biologic naive and treated with non-biologic DMARDs

Who cannot join

diagnosis of other inflammatory arthritis

About this study

Official title: Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data

This study will assess the rates of serious adverse events and death in adult rheumatoid arthritis patients treated with etanercept over the long-term in real-life clinical practice. It will also assess whether there is any difference in the rate of serious adverse events in patients trated with etanercept in comparision to patients treated with conventional disease-modifying anti-rheumatic drugs (DMARDs). The study will in addition quantify the efficacy of etanercept in this population by assessing the rates of important clinical outcomes such as changes in disease activity and disability/functioning.

Read the detailed description

patients recruited sequentially as seen in clinical practice

Conditions: Rheumatoid Arthritis
Being tested: etanercept, non-biologic anti-rheumatic drugs
Keywords: observational, non-interventional, cohort, retrospective, register, rheumatoid arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

etanerceptDrug
use as per routine clinical practice
non-biologic anti-rheumatic drugsDrug
use as per routine clinical practice (methotrexate, azathioprine, cyclophosphamide, cyclosporine, leflunomide, other)

Study groups in NCT01646385
Study group	Role	What they receive
etanercept		adult rheumatoid arthritis patients initiating therapy with etanercept as their first biologic therapy Receives: Drug: etanercept
nbDMARD		biologic-naive adult rheumatoid arthritis patients with DAS28 >4.2 treated with non-biologic anti-rheumatic drugs(s). Receives: Drug: non-biologic anti-rheumatic drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

Crude Incidence Rate of Malignancy
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000.
Measured: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Crude Incidence Rate of Lymphoproliferative Malignancy (LM)
Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000. Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes. LMs included lymphoma, myeloma, and leukemia. Adverse outcome was defined as 'lymphoproliferative malignancy' in the field [lymphopro] labeled by BSRBR.
Measured: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Crude Incidence Rate of Serious Infections
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000. Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death. Adverse outcome was defined as 'serious infection' in the field [serinf] labeled by BSRBR.
Measured: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Crude Incidence Rate of Other Serious Adverse Events
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000. Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs.
Measured: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Crude Incidence Rate of All-Cause Mortality
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000. Death was recorded in the adverse outcomes table and in the consultant follow-up table. Where multiple events described death for the same participant, date of death was taken as per the earliest record.
Measured: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years

Secondary outcomes (10)

Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation
Participants who switched from etanercept to either DMARDs or alternative biologic drug are reported.
Measured: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Time on Etanercept Therapy
Time on etanercept therapy was calculated by Kaplan-Meier survival analysis.
Measured: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline
DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the serological markers of inflammation (erythrocyte sedimentation rate [ESR, millimeter per hour] or C-reactive protein [CRP, milligram per liter]) and patient's general health assessment (recorded on a Visual Analog Scale [VAS] of 0 millimeter [mm]-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.
Measured: Baseline
Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5
DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.
Measured: Baseline, Year 1, 2, 3, 4, 5
Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)
DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.
Measured: Year 1, 2, 3, 4, 5
Time to Remission
DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity. Time to achieve remission was calculated by Kaplan-Meier survival analysis.
Measured: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Health Assessment Questionnaire (HAQ) Score at Baseline
HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
Measured: Baseline
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3
HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
Measured: Baseline, Year 1, 2, 3
Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score
HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3. Participants who had HAQ total score <=0.5 were considered in remission state.
Measured: Year 1, 2, 3
Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept
HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
Measured: 6 months prior to and 6 months post switching etanercept

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Aug 2012

First posted20 Jul 2012 (estimated)
Study startFeb 2012
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 6,393 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01646385
Sponsor's protocol ID: B1801348
Status last verified: Jul 2014
First submitted: 12 Apr 2012
Last updated: 5 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data
ClinicalTrials.gov ID: NCT01646385
Acronym / sponsor ID: B1801348
Conditions: Rheumatoid Arthritis
Keywords: observational, non-interventional, cohort, retrospective, register, rheumatoid arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 6,393 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 20 Jul 2012 (estimated)
Results: Posted 5 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

patients recruited sequentially as seen in clinical practice

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
etanercept	–	Drug: etanerceptadult rheumatoid arthritis patients initiating therapy with etanercept as their first biologic therapy
nbDMARD	–	Drug: non-biologic anti-rheumatic drugsbiologic-naive adult rheumatoid arthritis patients with DAS28 >4.2 treated with non-biologic anti-rheumatic drugs(s).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: adult patients with a diagnosis of rheumatoid arthritis

Key inclusion criteria (4 listed)

adult
rheumatoid arthritis
group 1: initiating etanercept as first biologic therapy
group 2: DAS28<4.2, biologic naive and treated with non-biologic DMARDs

Key exclusion criteria (1 listed)

diagnosis of other inflammatory arthritis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
etanerceptuse as per routine clinical practice	Drug	etanercept
non-biologic anti-rheumatic drugsuse as per routine clinical practice (methotrexate, azathioprine, cyclophosphamide, cyclosporine, leflunomide, other)	Drug	nbDMARD

Primary outcome

Crude Incidence Rate of Malignancy
Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000.
Crude Incidence Rate of Lymphoproliferative Malignancy (LM)
Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000. Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes. LMs included lymphoma, myeloma, and leukemia. Adverse outcome was defined as 'lymphoproliferative malignancy' in the field [lymphopro] labeled by BSRBR.
Crude Incidence Rate of Serious Infections
Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000. Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death. Adverse outcome was defined as 'serious infection' in the field [serinf] labeled by BSRBR.
Crude Incidence Rate of Other Serious Adverse Events
Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000. Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs.
Crude Incidence Rate of All-Cause Mortality
Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000. Death was recorded in the adverse outcomes table and in the consultant follow-up table. Where multiple events described death for the same participant, date of death was taken as per the earliest record.

10 secondary outcomes

Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation
Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Time on Etanercept Therapy
Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline
Time frame: Baseline
Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5
Time frame: Baseline, Year 1, 2, 3, 4, 5
Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)
Time frame: Year 1, 2, 3, 4, 5
Time to Remission
Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Health Assessment Questionnaire (HAQ) Score at Baseline
Time frame: Baseline
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3
Time frame: Baseline, Year 1, 2, 3
Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score
Time frame: Year 1, 2, 3
Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept
Time frame: 6 months prior to and 6 months post switching etanercept

Results and safety

Results posted to the registry on 5 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etanercept	3,529	2,691
nbDMARDs	2,864	1,993

Primary outcome: Crude Incidence Rate of Malignancy

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years. Number. Unit: events per 1000 participant-years

Measure	Etanercept n = 3529	nbDMARDs n = 2864
Value	14.7	23.9

Etanercept vs nbDMARDs: Hazard Ratio (HR): 0.836 (95% CI 0.683 to 1.025), p = 0.084, Regression, Cox

Population analysed: Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.

Primary outcome: Crude Incidence Rate of Lymphoproliferative Malignancy (LM)

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years. Number. Unit: events per 1000 participant-years

Measure	Etanercept n = 3529	nbDMARDs n = 2864
Value	1.1	2.6

Etanercept vs nbDMARDs: Hazard Ratio (HR): 0.512 (95% CI 0.276 to 0.952), p = 0.035, Regression, Cox

Primary outcome: Crude Incidence Rate of Serious Infections

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years. Number. Unit: events per 1000 participant-years

Measure	Etanercept n = 3529	nbDMARDs n = 2864
Value	35.1	36.2

Etanercept vs nbDMARDs: Hazard Ratio (HR): 1.019 (95% CI 0.831 to 1.251), p = 0.855, Regression, Cox

Primary outcome: Crude Incidence Rate of Other Serious Adverse Events

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years. Number. Unit: events per 1000 participant-years

Measure	Etanercept n = 3529	nbDMARDs n = 2864
Value	20.3	29.6

Etanercept vs nbDMARDs: Hazard Ratio (HR): 0.700 (95% CI 0.564 to 0.870), p = 0.001, Regression, Cox

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etanercept	944 of 3,529 (26.7%)	0 of 0	Not reported
nbDMARDs	744 of 2,864 (26%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Crude Incidence Rate of Malignancy (time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01646385.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.